Regulatory Affairs Specialist – Thailand
ประกาศจากแหล่งภายนอกคุณสมัครได้โดยตรง — เราจะพาคุณไปยังหน้าสมัครงานของบริษัท ไม่ต้องสมัครสมาชิก ไม่มีคนกลาง ไม่ต้องล็อกอิน ThaiJobz
เกี่ยวกับตำแหน่ง
As a Regulatory Affairs Specialist, you will manage end-to-end regulatory activities for product registrations and compliance in Thailand, ensuring accuracy in global databases and timely submissions. This role involves partnering with cross-functional teams and external agencies to support business objectives.
รายละเอียดงาน
Your Role: Regulatory Affairs Specialist
As a Regulatory Affairs Specialist, you will be part of the Thailand Regulatory team to deliver product registrations, variation filings, and technical transfers. In this role, you’ll be responsible for maintaining licenses, updating global regulatory databases, and ensuring compliance with local and international safety requirements.
Your Responsibilities:
- Manage end-to-end regulatory activities including initial registrations, variations, renewals, and Marketing Authorization Transfers for the Thailand market.
- Maintain the Global Regulatory database and internal documentation systems to ensure all product licenses and legal records are accurate and up-to-date.
- Partner with cross-functional teams (Supply Chain, Quality, Marketing) and external regulatory agencies to support business objectives and shape the regulatory environment.
- Oversee Pharmacovigilance activities by monitoring adverse events and ensuring timely submission of drug safety reports per Elanco SOPs and local laws.
- Review and approve promotional, educational, and artwork materials to ensure full regulatory compliance and brand protection.
What You Need to Succeed (minimum qualifications):
- Education: Bachelor’s Degree in Pharmacy
- Experience: A minimum of 3 years of experience in regulatory affairs
- Proficiency in Thai and English (written/spoken) and strong organizational skills for managing sensitive information.
What will give you a competitive edge (preferred qualifications):
- Ability to network effectively across diverse groups and organizational levels.
- Proven experience managing multiple projects simultaneously while meeting strict deadlines.
- High learning agility with the ability to prioritize work effectively in a fast-paced environment.
- Experience with artwork management systems (e.g., BLUE system).
- Strong interpersonal skills with a focus on follow-through and problem resolution.
Additional Information:
Location: Bangkok, Thailand - [insert work model]
คุณสมบัติผู้สมัคร
- ประสบการณ์
- 3-5 ปี
- การศึกษา
- ปริญญาตรี